Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty (MAGIC)
Computational μFR-Guided Versus Angiographic Guidance In Drug-Coated Balloon Angioplasty: a Randomized Controlled - Study MAGIC Trial
The MAGIC trial is an investigator-initiated, multicenter, randomized (1:1) interventional study designed to evaluate whether drug-coated balloon (DCB) angioplasty guided by computational μFR assessment is superior to conventional angiographic-guided DCB angioplasty in terms of acute physiological outcomes.
The study will enroll approximately 250 patients with de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.0-4.0 mm. Participants will be randomized to one of two treatment strategies.
In the angiography-guided control group, DCB angioplasty will be performed according to conventional angiographic criteria for an optimal procedural result, including TIMI grade 3 flow, residual stenosis of less than 30%, and absence of coronary artery dissections of type C or greater.
In the μFR-guided group, computational μFR will be assessed at baseline, after lesion predilation, and after DCB treatment. Virtual percutaneous coronary intervention (PCI) will be recommended to guide and optimize the angioplasty strategy, with the aim of achieving a final μFR value ≥0.86. If the physiological result remains suboptimal (μFR <0.86) despite further lesion preparation, a hybrid strategy involving implantation of a drug-eluting stent (DES) will be permitted.
The primary endpoint is the proportion of target vessels with a post-procedure μFR value ≥0.86, as assessed by an independent, blinded core laboratory through analysis of final coronary angiograms.
Clinical follow-up will be conducted exclusively by telephone over a total period of 24 months.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Stefano Galli, Cardiologist, MD
- 電話番号：+39 02 5800 2533
- メール：stefano.galli@cardiologicomonzino.it
研究連絡先のバックアップ
- 名前：Simone Fezzi, Cardiologist, MD, Msc
- 電話番号：+39 045 812 2320
- メール：simone.fezzi@aovr.veneto.it
研究場所
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Brescia、イタリア
- まだ募集していません
- Fondazione Poliambulanza Istituto Ospedaliero
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コンタクト：
- Diego Maffeo Diego, MD
- メール：diego.maffeo@poliambulanza.it
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CS
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Cosenza、CS、イタリア、87100
- まだ募集していません
- Azienda ospedaliera di Cosenza "Annunziata"
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コンタクト：
- Alberto Polimeni, MD, PhD
- メール：alberto.polimeni@unical.it
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MI
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Milan、MI、イタリア、20138
- 募集
- Centro Cardiologico Monzino - IRCCS
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コンタクト：
- Stefano Galli, MD
- 電話番号：+39 02 5800 2533
- メール：stefano.galli@cardiologicomonzino.it
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VR
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Verona、VR、イタリア、37126
- まだ募集していません
- AOUI Verona - Borgo Trento
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コンタクト：
- Simone Fezzi, MD, Msc
- 電話番号：+39 045 812 2320
- メール：simone.fezzi@aovr.veneto.it
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥18 years
- Patients with a clinical indication to PCI, either for stable coronary artery disease or acute coronary syndromes
- Presence of a de novo lesion in a native coronary artery with a reference vessel diameter >2.0 mm and ≤4.0 mm by visual estimation
- Lesion length up to 60 mm
- Written informed consent for study participation
Exclusion Criteria:
- Recent ST-elevation myocardial infarction (within 48 hours)
- Presence of visible thrombus at the target lesion site
- Participation in another investigational clinical trial
- Women who are pregnant or breastfeeding
- Severe renal impairment, defined as creatinine clearance or eGFR <30 ml/min
- Left ventricular ejection fraction <30%
- Estimated life expectancy <12 months
- Culprit lesion with stenosis >99% and/or TIMI flow <2
- Target lesion not pre-dilated or with unsuccessful pre-dilatation (residual stenosis >30%)
- Marked vessel tortuosity preventing device delivery (per investigator's judgment)
- Prior stent implantation in the target segment
- Bifurcation lesion where side branch treatment is anticipated
- Left main stenosis >50% or target lesion located in the left main
- Target lesion within a saphenous vein graft
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Angio-Based Group (Control)
In the angiography-guided control group, DCB angioplasty will be performed according to conventional angiographic criteria for an optimal procedural result, including TIMI grade 3 flow, residual stenosis of less than 30%, and absence of coronary artery dissections of type C or greater. |
|
|
実験的：μFR-Based Group (Intervention)
In the μFR-guided group, computational μFR will be assessed at baseline, after lesion predilation, and after DCB treatment. Virtual percutaneous coronary intervention (PCI) will be recommended to guide and optimize the angioplasty strategy, with the aim of achieving a final μFR value ≥0.86. If the physiological result remains suboptimal (μFR <0.86) despite further lesion preparation, a hybrid strategy involving implantation of a drug-eluting stent (DES) will be permitted. |
Drug-coated balloon (DCB) angioplasty guided by computational μFR assessment. μFR is measured at baseline, after lesion predilation, and after DCB treatment. Virtual PCI based on μFR is recommended to guide lesion preparation and optimize the angioplasty strategy, targeting a final μFR value ≥0.86. If μFR remains <0.86 despite further lesion preparation, a hybrid strategy involving drug-eluting stent (DES) implantation is permitted. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Target Vessels With Post-Procedure μFR ≥0.86
時間枠：During procedure
|
The primary efficacy endpoint is the proportion of target vessels achieving a post-procedure μFR value ≥0.86, as assessed by an independent, blinded core laboratory based on analysis of the final coronary angiograms. |
During procedure
|
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Incidence of Major Clinical Safety Events at 30 Days
時間枠：30 days after the index procedure
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Incidence of the composite safety endpoint including BARC type 3 or 5 bleeding, definite lesion thrombosis or target-segment occlusion, any stroke, any myocardial infarction, and cardiovascular death. The endpoint will be assessed at 30 days after the index procedure. |
30 days after the index procedure
|
協力者と研究者
捜査官
- 主任研究者：Stefano Galli, Cardiologist, MD、Centro Cardiologico Monzino - IRCCS
- スタディチェア：Simone Fezzi, Cardiologist, MD, Msc、Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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